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I-InTERACT Preterm

NCT05282628 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-02-06

No results posted yet for this study

Summary

Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (\< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

Conditions

  • Pre-Term

Interventions

BEHAVIORAL

Building Better Brains and Behavior program (B4 Preterm)

The program couples online learning modules with video conferencing sessions with a trained therapist to review skills and practice implementing the skills with live coaching. Online modules include didactic content, video clips of parents modeling the skills, and exercises. Parents will complete intervention modules sequentially in conjunction with scheduled 1:1 videoconference sessions with a trained therapist. Videoconference sessions with the therapist will be scheduled weekly, once parents have completed their modules. During these sessions, the therapist will review the online materials and provide active coaching to the parent on how to use the skills with their child (e.g., labeled praise, reflective responses). Each session follows a manualized therapy protocol to optimize content fidelity. Parents will be instructed to practice the parenting skills for 5 minutes each day to promote mastery in the home environment.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Shari L Wade, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Months
Max Age
96 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282628 on ClinicalTrials.gov